Medical Devices

A pharmaceutical company came to Battelle for help in redesigning the cap and mouthpiece of a nebulizer using human centric design (HCD) principals. At the same time, they were considering adding a prescription management feature to monitor the usage and dosage of the drug.

Battelle conducted contextual research in a series of smaller hospitals to better understand the process of dispensing daily medication to patients. We observed hospital environments with different procedures and equipment in place, and created a report highlighting the operational differences.

An infusion pump manufacturer came to Battelle for help in putting together a responsible disclosure policy. While their device had not been hacked, they realized that the life-critical nature of the device gave it a very high risk profile and made it likely to come under heavy scrutiny from security researchers.

Fuzz testing is commonly used as a first step in assessing the vulnerability of a device to malicious hacking or unintended effects caused by bad data. A company came to Battelle for help in designing and executing a fuzz test protocol and interpreting the results in way that made them understandable and actionable.

A large pharmaceutical client came to us for evaluation of their Instructions For Use (IFU) for an injection device. They had been working with a design firm to develop the IFU, and had added a large number of images in the hopes of making the IFU easier to understand.

A large medical device manufacturer asked us to perform a human factors study on an autoinjector. We observed some inversions where users would have injected their thumbs instead of the desired injection site if the device they were using had been real.

A pharmaceutical client added an exhaust sound suppressor to their autoinjector to quiet the device. The FDA thought that this fundamentally changed the device by removing an auditory signal of injection completion and wanted revalidation of the new design for usability.

A pharmaceutical company was evaluating potential options for a combination drug and injection device for a highly viscous drug. There were custom-made and commercial-off-the-shelf (COTS) options available. They came to Battelle for help in deciding which one would be most likely to be accepted by their end users.